Bradley Merrill Thompson Quoted in Article, “Mobile Health Apps: Blackburn’s SOFTWARE Act Would Limit FDA’s Power, Ensure Regulatory Restraint”

Forbes

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "Mobile Health Apps: Blackburn's SOFTWARE Act Would Limit FDA's Power, Ensure Regulatory Restraint."

Following is an excerpt:

In October, FDA introduced the SOFTWARE Act, which defines three different categories of mHealth software: Medical, clinical, and health. Under the SOFTWARE Act, only medical software would require FDA approval. ?...

Nevertheless, the final guidance had been delayed by a coalition of mHealth providers, which hoped that it could be stalled long enough for them to encourage Congress to act. ?...

Another group of businesses, the mHealth Regulatory Coalition, warned against new legislation that will upset the regulatory applecart for no purpose.

I interviewed Brad Thompson, the mHealth Regulatory Coalition's general counsel, who told me that his members are not against new legislation — but only as, if, and when needed. ?...

One of Mr. Thompson's criticisms of the SOFTWARE Act is that it defines three different categories of mHealth software, but that these boundaries are blurry, and the technologies are converging. He also also points out that the SOFTWARE Act might deregulate more than its authors intend. ?...